JP4772285B2 - Applicator, dispenser, and method for dispensing and applying adhesive material - Google Patents

Description

  This application is a CIP application filed on Feb. 7, 2003 and claims the benefit of the filing date of US Application No. 10 / 359,699.

The present invention relates to applicators, dispensers for dispensing and applying adhesive materials, such as polymerizable monomer compounds, such as, for example, cyanoacrylate adhesives, particularly for medical applications.

Numerous swabs, applicators, dispensers, and kits are known for dispensing and applying various materials, including adhesive materials. However, these known equipment has various drawbacks that make them undesirable in many applications.

  Monomer and polymer adhesives are used in both industrial and medical applications (including household use). Among these adhesives include 1,1-2 group substituted ethylene monomers and polymers such as α-cyanoacrylate. Since the adhesive properties of such monomers and polymers were discovered, they have found wide use because of the rate at which they cure, the strength of the resulting bond formed, and the relative ease of use. These properties have given the α-cyanoacrylate adhesive a major choice for a variety of applications such as bonding plastics, rubber, glass, metal, wood, and more recently biological tissue.

  The medical use of 11-2 substituted ethylene monomer adhesive compositions is as an alternative or appendage to surgical sutures and clasps in wound closures and to lacerations, abrasions, burns, stomatitis, swellings, and other open surfaces Includes use to cover or protect tissue wounds, such as wounds. When such an adhesive is applied, it is usually applied in its monomeric form and the resulting polymer produces the desired adhesive bond.

Applicators for dispensing polymerizable and / or crosslinkable materials, such as 11-disubstituted ethylene blends, are disclosed in Leung et al., U.S. Pat.No. 5,928,611 and pending on October 29, 1999. It is disclosed in patent application No. 09 / 430,177. In general, many different 1,1-disubstituted ethylene formulations can be used, for example, as fast acting surgical adhesives, sealants, bioactive agent release matrices, cyanoacrylate formulations, medical, surgical and other in vivo applications. It is known for various uses such as used implants. Such formulations also include those disclosed by Leung and the references cited therein.

  However, it has been very difficult to design an effective and commercially viable applicator and / or dispenser because of the need to apply adhesive in its monomer type and because of the rapid polymerization rate of the monomer. It was. The applicator and / or dispenser does not cause premature polymerization of the monomer, the monomer is easily applied, the monomer polymerizes to the application at the desired rate, and the hygienic and / or bactericidal properties of the monomer and applicator -Competing demands on what is actually or recognized-maintained must be made up. The latter requirement of maintaining the reality or perceived hygiene and sterilization of the monomer and applicator prevents the user and / or patient from seeking clean products and introducing additional bacteria or foreign substances into the wound site. Is particularly important in medical applications.

  A further problem in addressing the above requirements for adhesive applicators and / or dispensers is the need to provide a stable monomer product. In particular, small amounts of cyanoacrylate monomer tend to give premature polymerization that renders the product useless. Therefore, industrial products of monomer adhesive compositions had to balance a rapid cure rate during storage and a high bond strength. The shelf life of these adhesives is primarily related to stability (ie, stability of composition properties), uncured physical properties, rate of cure of the adhesive, and final effect properties of the composition. For example, the shelf life of the monomer α-cyanoacrylate composition can be measured as a function of the time that the composition can be stored before an inadequate level of polymerization occurs, as measured by an increase in viscosity. Unapplicable levels are dictated by the level of polymer product that reduces the usefulness of the composition in the application in which it is produced.

Known devices do not provide optimal applicators and / or dispensers for the successful dispensing and application of adhesive material on various surfaces and structures. Known applicators are generally either optimal for transport to other compositions or are inconvenient for use in bonding with adhesives. Furthermore, the conventional device does not address the competing need for ease of use and adhesive stability prior to application.

  The present invention addresses the above-mentioned needs by providing applicators and dispensers that allow for economical and efficient use of adhesive compositions. In embodiments of the invention, applicators and / or dispensers that are more user friendly are provided. In an embodiment of the invention, a more ergonomic applicator and / or dispenser is provided. In an embodiment of the present invention, an applicator and / or dispenser is provided whereby the amount of adhesive material is successfully applied. The applicator and / or dispenser can be either easily disposed of or reusable depending on the desired application.

In an embodiment, the applicator and / or dispenser is designed to facilitate manipulation by a hand to dispense and / or apply adhesive. For example, in an embodiment of the present invention, a pen-like applicator and / or dispenser is provided to provide a user-friendly feeling. In an embodiment, the applicator and / or dispenser is designed to be more comfortable to the user, easier to grip and / or easier to operate.

  In embodiments, the applicator and / or dispenser provides applicable stability and shelf life without the need to add another stabilizer material to the polymerizable monomer to the adhesive composition. Therefore, in these embodiments, the shelf life is provided to the applicator and / or the dispenser itself so that the cure rate of the adhesive composition is not adversely affected when one or more stabilizers are added. . Thus, the need to provide another polymerization initiator or rate modifier can be reduced or even eliminated.

In other embodiments, the applicator and / or dispenser includes a polymerizable initiator or accelerator for the adhesive material. The polymerizable initiator or accelerator can be placed at or on the tip or other part of the applicator. The polymerization initiator or accelerator can be absorbed or adsorbed into the porous portion of the applicator, or can be coated on the surface of the applicator or others incorporated in the applicator portion. The applicator and / or dispenser can also include a bendable barrier that separates the first and second compartments, for example, to retain a polymerization initiator or accelerator separated from the adhesive material prior to use.

In particular, the present invention is an applicator / dispenser for dispensing and / or applying adhesive material comprising:
A first body part and a second body part, at least one of which is movable relative to the other of the first and second body parts;
A cavity in at least one of the first body portion and the second body portion;
An applicator / dispenser comprising a penetrating or cutting member installed in at least one of the first body part and the second body part,
Intended to single operation relative first and second body portion against the other ones of said first and second body portion, characterized in that moving the penetrating or cutting member into the cavity To do. In various embodiments, further applicator / dispenser, made from a container of adhesive material disposed on at least a portion of the cavity, relative first against the other of said first and second body portions And one action of the second body part is characterized by moving the penetrating or cutting member to destroy the container.

  In an embodiment, the adhesive material comprises a polymerizable monomer adhesive material. In an embodiment, the adhesive material comprises a polymerizable 1,1-2 group substituted ethylene monomer blend. In yet another embodiment, the adhesive material comprises a cyanoacrylate formulation.

  In an embodiment, the applicator / dispenser for a polymerizable monomer adhesive material is a material that provides stability and storage time applicable to the adhesive composition without the need to add another stabilizer material to the polymerizable monomer. including. As noted above, since the shelf life is provided by the applicator and / or dispenser material, the cure rate of the adhesive composition is not adversely affected. Therefore, the need to apply another polymerization initiator or rate modifier can be reduced or omitted.

  In other embodiments, the applicator / dispenser includes a polymerization initiator or accelerator for the adhesive material.

  In an embodiment, the applicator dispenser further comprises a rotating coupling portion movably coupled to the first and second body portions. In an embodiment, the first and second body portions may comprise applicator / dispenser handle portions.

In another embodiment, the second body portion is rotatable relative against the first body portion. In an embodiment, the applicator / dispenser further comprises a cam disposed on one of the first and second body portions other than one of the first and second body portions having a penetrating or cutting member disposed thereon. made from the surface, the rotation of the relative second body portion against the first body part moves by contacting the penetrating or cutting member and the cam surface into the through or cutting member cavity.

In an embodiment, the applicator / dispenser further comprises a blender disposed at least in part within the cavity and at least partly flexible.
A container of adhesive material disposed in the blender and located at least in the cavity;
Relative first and one operation of the second body portion against the other of the first and second body portions to move the penetrating or cutting member, characterized in that destroying the container.
Is moved to destroy the container. In an embodiment, the applicator / dispenser further comprises a plug member disposed in at least a portion of the blender opening, wherein the applicator / dispenser is made of a material having at least one of a porous, absorptive, and absorptive property. A plug member. In an embodiment, the plug member consists of an applicator tip.

In an embodiment, the applicator / dispenser further comprises a slide assembly having a plunger portion disposed in at least a portion of the cavity and a slide portion disposed in at least a portion of the cavity. The assembly includes a slide assembly that is slidable to move the plunger portion toward the dispensing opening of the cavity, and first and second body portions that extend the slide portion of the slide assembly. And at least one opening. In an embodiment, the applicator / dispenser further comprises a container of adhesive material disposed within the cavity between the dispensing opening of the cavity and the plunger portion of the slide body, the other of the first and second body portions. relative first and one operation of the second body part against the will move through or cutting member, to destroy the vessel, operation of the slide member may move the plunger unit is destroyed once the container And the adhesive material is dispensed from the cavity.

In another embodiment, the present invention comprises at least one applicator / dispenser and a plurality of containers of adhesive material arranged to be placed in at least one part in a cavity of said at least one applicator / dispenser. A kit,
Relative first and one operation of the second body portion against the other of the first and second body portions to move the penetrating or cutting member, one of the containers disposed in at least a portion of the cavity Intended for kits characterized by destruction. In an embodiment, the kit further comprises a plurality of movable applicator tips. In an embodiment, the kit further comprises a polymerization initiator or rate modifier for the adhesive material. In an embodiment, the at least two plurality of containers comprise different amounts of adhesive material. In other embodiments, the at least two plurality of containers comprise different adhesive materials.

In another embodiment, the present invention places a container of adhesive material at least in part into the applicator / dispenser cavity,
For relative first and one operation of the second body portion against the other of the first and second body portion, destroy the installed containers in at least a part of the cavity, through or cutting member Move
A method of applying / dispensing the adhesive material comprising dispensing the adhesive material from the cavity is contemplated. In an embodiment, the method further comprises applying the dispensed adhesive to the material to be bonded.

  Various other features and advantages of the present invention will be made apparent from the following detailed description of exemplary embodiments.

  Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

  In an embodiment of the present invention, an applicator / dispenser is provided that facilitates simple application of a desired amount of polymerizable adhesive material. In an embodiment, the amount of polymerizable adhesive material is packaged in the applicator / dispenser in a fragile unpool that disrupts the activity of the applicator / dispenser. The fragile ampere can provide stability and / or storage time for the amount of polymerizable adhesive material.

Although the present invention is not limited to the particular design depicted herein, FIGS. 1-4 illustrate a first embodiment (reference embodiment) of the present invention. As shown in FIGS. 1 and 2, applicator / dispenser 100 is formed by a first body portion 110 and a second body portion 120 that are movable relative to the other. For example, in the illustrated embodiment, the first body portion 110 and the second body portion 120 are illustrated in FIG. 1 from a relatively spaced opening from the substantially closed adjacent illustrated in FIG. A rotational connection 130 is provided that is movable to a position. The relative position illustrated in FIG. 1 can be a cocked position in an embodiment having an amount of polymerizable adhesive material pre-packaged in applicator / dispenser 100.

The first body part 110 and the second body part 120 define a space in which the blender can be fixed. As shown in FIGS. 1 and 2, the first body portion 110 has an opening 112 through which the push button portion 142 of the blender 140 can be extended. As explained below, the push button 142, the desired amount of polymerizable adhesive material, for example, through separable or replaceable chip 150, from the applicator / dispenser 100, by the user to dispense Pressed. The user's thumb or finger can be used to push the push button 142, while the applicator / dispenser 100 is held by the first and second body parts 110, 120 as a handle. For example, the user can hold applicator / dispenser 100 as a pen and press push button 142 with his index finger.

  It should be understood that the detachable or replaceable chip 150 is optional and can take any desired structure. If a separable or replaceable tip 150 is not provided or used, the porous plug 170 can form the tip of the dispenser / applicator 100 as described below. The tip 150 can be selected for a particular application and is not limited to the tapper nozzle design shown. For example, the applicator tip can be a fiber swab, sponge swab, foam swab, brush, spatula, and the like. Suitable tips known or developed here can be used with the applicator / dispenser according to the invention.

The tip 150 can be designed to friction fit over the distal portion 160 of the applicator / dispenser 100. Alternatively, the tip 150 can be secured directly on the porous plug 170 located at the open end of the bladder 140 as described below.

The first body portion 110, the second body portion 120, the blender 140 and / or the chip 150 may be used to stabilize any suitable material, preferably a polymerizable adhesive material to be dispensed to avoid premature polymerization. It can be made of a material that promotes sex.

The porous plug 170 can include a polymerization initiator or a rate modifier for the polymeric adhesive material to be dispensed . The porous plug 170 may include a polymerization initiator or a speed regulator, or may have a polymerization initiator or a speed regulator coated on the surface thereof.

FIG. 3 shows an exemplary embodiment of the blender 140 removed from the applicator / dispenser 100. As described above, the blender 140 has an open end 144 in which the porous plug 170 is secured. The blender 140 can be blow molded from a suitable rubber, silicone or plastic material such as polyvinyl chloride, polyethylene, polyurethane, natural or nitrile rubber, or any combination thereof.

A fragile unpool 146 containing an amount of polymerizable adhesive 148 is placed in blender 140. The frangible ampere 146 can be made of any suitable material, preferably a material that improves the stability and shelf life of the polymerizable adhesive material 148. For example, the fragile unpool 146 can be made of glass. Other materials can be used for the fragile unpool, for example, a plastic material, such as a material that can be perforated, such as aluminum. Examples of suitable ampoules that can be used in the dispenser / applicator of the present invention are described, for example, in US Pat. No. 5,928,611, the entire disclosure of which is hereby incorporated by reference. In fact, when using the unpool in the present invention, it is possible to use not only the unpool 144 but also the entire unpool / applicator device that constitutes the porous plug 170. In this embodiment, the dispenser / applicator of the present invention is particularly suitable for dispensing or applying adhesives including DERMANBOND® topical skin adhesive products available from Ethicon (Somerville, New Jersey).

FIG. 4 shows the bladder 140, push button assembled and inserted into the space between the first body portion 110 and the second body portion 120 having a porous plug 170 extending through an opening in the distal portion 160 of the applicator / dispenser 100. 142, a fragile unpool 146 and a porous plug 170 are illustrated. As shown in FIG. 4, the second body portion 120 includes a penetrating or cutting member 122 that extends inwardly from its inner surface. The cutting member 122 is such that when the first and second body parts 110, 120 move from the opening shown in FIG. 1 to the closing part shown in FIG. Located in. The first and second body portions 110, 120 act as levers on the rotary joint and thus provide a mechanical advantage to facilitate breakage of the fragile unpool 146.

  Once the first and second body parts 110, 120 are moved to the closed position shown in FIG. 2, the fragile unpool 146 is broken, and the first and second body parts 110, 120 are accidentally shown in FIG. It is possible to prevent return to the open position. For example, detents or other suitable latching mechanisms can be used to engage the first and second body portions 110,120. The applicator / dispenser 100 can make the latch mechanism irreversible in embodiments where only the amount of polymerizable adhesive material 148 initially applied is used.

In the embodiment shown, the cutting member 122 is positioned proximate the open end 144 of the bladder 140 away from the push button 142. This position is the open end 144 fragile to be broken of the vicinity Ampere 146 of the bladder 140, it flows from the polymerizable adhesive bladder 140, to ensure unimpeded by larger fragments of Ampere that its flow is broken Help. In addition, the breakage of the fragile unpool 146 away from the push button portion 142 helps to avoid fragments that may accidentally penetrate the push button 142 and cut the user's thumb or finger. it can. Although not shown, the bladder 140 can be thicker or strengthened with a push button 142 to prevent the appearance. Alternatively, the unpool 146 can be placed in a separate tubular structure, such as a standard butyrate tube having a removed portion, such as a partially open end. Fragments of unpooled 146 can be contained by the tube while allowing the polymerizable adhesive 148 to flow from the tube and bladder 140.

The bladder 140 is designed to include a polymerizable adhesive 148 once the fragile unpool 146 breaks. The polymerizable adhesive 148 is affected by the bladder 140 by pressing the push button portion 142 to display the polymerizable adhesive 148 and allow it to flow through the porous plug 170. The polymerizable adhesive 148 flowing through the porous plug 170 can be applied directly to the desired site using the porous plug 170 as an applicator tip. Alternatively, the removable or separable tip 150 can receive a polymerizable adhesive 148 that flows through the application porous plug 170.

A controlled flow of the polymerizable adhesive 148 is obtained by providing a slow but steady pressure of the bladder 140, for example, by pressing the push button portion 142 to a desired degree and / or for a desired time. . In an embodiment, the deposit displayed by pressing the push button portion 142 can correspond to the desired amount of polymerizable adhesive 148 to be dispensed .

As described above, the amount of polymerizable adhesive material 148 can be pre-included in the applicator / dispenser 100. The applicator / dispenser 100 can be disposable and discarded after the amount of polymerizable adhesive material 148 in the fragile unpool 146 has been dispensed or otherwise used (eg, polymerized). Alternatively, an amount of polymerizable adhesive material 148 can be separated from applicator / dispenser 100 and delivered to applicator / dispenser 100 prior to use.

In an embodiment, the user can select various adhesive materials and / or amounts by selecting an unpool and / or bladder member (blader, unpool and plug) to be placed in the applicator / dispenser 100. For example, a kit can be provided that includes at least one applicator / dispenser 100 and a plurality of frangible unpools 146 (or bladder members). Multiple disposable or separable tips 150 can also be included in the kit. The kit can also contain a cleaning agent such as isopropyl alcohol, or a chemical sterilizing agent such as gluteraldehyde. Part of the kit can include the fragile unpool 146 (or bladder member) separately into, for example, a blister pouch, etc. and can be unpacked or combined with the required applicator / dispenser 100. .

Although the present invention is not limited to the specific designs described herein, FIGS. 5-9 illustrate a second embodiment (reference embodiment) of the present invention. As shown in FIGS. 5 and 6, the applicator / dispenser 200 is formed by a first body part 210 and a second body part 220 that are movable relative to each other. For example, in the illustrated embodiment, the swivel connection 230 moves the first body portion 210 and the second body portion 220 from an open portion as shown in FIG. 5 to a substantially closed portion as shown in FIG. Provided to make it possible. The opening portion illustrated in FIG. 5 may be a cocked portion in an embodiment having an amount of polymerizable adhesive material pre-included in the applicator / dispenser 200.

  As shown in FIGS. 5 and 6, the first body part 210 has an opening through which the slide button part 242 of the slider part 240 can be extended. As described below, the slide button portion 242 is moved by the user to apply a desired amount of polymerizable adhesive material from the applicator / dispenser 200, eg, through a porous plug 270 or other suitable tip. be able to. While the user's thumb or finger can be used to move the slide button 242, the applicator / dispenser 200 can be grasped as a handle by the first and second body portions 210, 220. For example, the user can hold applicator / dispenser 200 as a pen and push or slide against slide button 242 with his index finger. The first torso portion 210 may include one or more contours for a user's thumb or finger.

  The slide button 242 is not limited to the specific embodiment shown in FIGS. The slide button 242 can be formed by a lever or other applicable mechanism such as a syringe shaft that is arranged to move toward the plunger portion 244.

FIG. 7 shows a cross-sectional view of an applicator dispenser 200 having first and second body portions 210, 220 in the opening. As shown, the first and second body portions 210, 220 reveal a chamber 260 into which a fragile unpool 280 containing an amount of polymerizable adhesive material 282 can be placed. As shown in FIG. 7, the first body part 210 has an opening 214 through which the slide button part 242 of the slide part 240 can be extended. In the embodiment shown, opening 214 is an elongated slot that allows the slide to move in the axial direction of applicator / dispenser 200. Therefore, as will be described below, the slide button portion 242 can be moved by the user because the plunger portion 244 of the slide portion 240 is movable. Once the fragile unpool 280 is broken, for example, by a penetrating or cutting member 222 provided on the second body 220, the movement of the plunger 244 toward the porous plug 270 causes the polymerizable adhesive material 282 to move. the to be dispensed from the applicator / dispenser 200.

  Although not shown, the second embodiment can also include a disposable or separable tip as described above with respect to the first embodiment.

  FIG. 8 shows an exemplary embodiment of the slide member 240 removed from the applicator / dispenser 200. The slide button part 242 and the plunger part 244 are coupled by an intermediate part 246 of the slide member 240. The intermediate portion 246 should be stiff enough to carry the plunger portion 244 against any resistance caused by the polymerizable adhesive material 282, between the plunger 244 and the chamber 260, and / or broken. Should contact the unpool 280. On the other hand, the slide button portion 242 may be made of a rubber material or a plastic material that provides a comfortable and / or appropriate grip for the user's finger or thumb. The plunger portion 244 can be made of a rubber material or plastic material that slides within the chamber 260, while the polymerizable adhesive material 282 prevents substantial leakage during use relative to the interior surface of the chamber 260. Provide adequate sealing. Alternatively, the plunger portion 244 can be provided with one or more seal rings of suitable material. The slide button part 242 and the intermediate part 246 can be made of any of various thermoplastics such as ABS, polycarbonate, ULTEM (registered trademark), and the like. The plunger portion 244 and / or the seal ring 248 can be made of any of a variety of rubbers (rubbers) such as natural, nitrile, and polyisoprene. Plunger portion 244 and / or seal ring 248 may be provided with a suitable lubricant so that it can slide, while maintaining contact with the inner surface of chamber 260. Preferably, the selected lubricants and materials do not react with the adhesive material and do not cause accelerated polymerization of the adhesive material.

  FIG. 9 illustrates the slide member 240, slide button 242, plunger portion 244, and fragile unpool 280 inserted into the chamber 260. As shown in FIG. 9, the penetrating or cutting member 222 extends internally from the inner surface of the second body 220. The cutting member 222 is installed such that the fragile unpool 280 is broken by the cutting member 222 when the first and second body portions 210, 220 move from the opening shown in FIG. 5 to the closing portion shown in FIG. Is done. The first and second body portions 210220 act as levers on the pivot joint 230 and thus provide a mechanical advantage that facilitates the breaking of the fragile unpool 280.

  As described above with respect to the first embodiment, once the first and second fuselage portions 210220 have moved to the closed portion shown in FIG. 6 and the fragile unpool 280 has been destroyed, the first and second fuselage portions. 210 and 220 can prevent accidental return to the opening shown in FIG.

  Although the cutting member 222 is located near the end of the fragile unpool 280 away from the porous plug 270 in the illustrated embodiment, the cutting member 222 and the fragile unpool are separated from the fragile unpool 280 by the polymerizable adhesive 282. Can be positioned to be broken near the end closer to the porous plug 270 to ensure that it is not impacted by a larger piece of unpooled 280 that has been broken. Further, the cutting member 222 is shown as a single local member, while the cutting member 222 can extend along a portion of the entire unpool 280 and / or can consist of multiple cutting members. It should be understood that it can. Furthermore, it should be understood that while unpool 280 is shown as a single unpool, it can provide multiple unpools. For example, one unpool can include an adhesive material while the other unpool can include a biologically active agent such as a drug, or other material.

Chamber 260 is designed to contain polymerized bioadhesive 282 once the fragile unpool 280 is destroyed. The polymerizable adhesive 282 is moved to the chamber 260 by moving the slide button portion 242 so that the plunger portion 244 of the slide member 240 displays the polymerizable adhesive 282 and allows it to flow through the porous plug 270. Can be affected. Polymerizable adhesive 282 that flows through the porous plug 270 may use a porous plug 270 as applicator tip directly applied to the desired site. Alternatively, disposable or detachable tip may receive the polymerizable adhesive 282 that flows through the dispenser Sir / applicator 200 for applying.

  A controlled flow of the polymerizable adhesive 282 can be obtained by moving the slide button portion 242 to a desired degree. In an embodiment, the movement of the slide member 240 can create pressure within the dispenser / applicator 200 to allow the polysynthetic adhesive 282 to flow.

As described above, the amount of polymerizable adhesive material 282 can be pre-included in the applicator / dispenser 200. Applicator / dispenser 200 may after being frangible used or other amount of polymerizable adhesive material 282 in Ampere 280 is dispensed (i.e. polymerized), and disposal or discard this is. Alternatively, the polymerizable adhesive material 282 can be separated from the applicator / dispenser 200 and supplied to the applicator / dispenser prior to use.

  In an embodiment, the user can select from various adhesive materials and / or quantities by selecting a fragile unpool to be inserted into the applicator / dispenser 200. For example, a kit can be provided that includes at least one applicator / dispenser 200 and a plurality of fragile unpools 280. Multiple disposable or separable chips can also be included in the kit.

Although the present invention is not limited to the particular design shown here, FIGS. 10-12 illustrate a third embodiment of the present invention (a pre-requisite embodiment of the present invention) . As shown in FIGS. 10 and 11, the applicator / dispenser 300 is formed by a first body part 310 and a second body part 320 that are movable relative to each other. For example, in the illustrated embodiment, the first body portion 310 can be formed by two members that are secured together to provide an open end 314 as shown in FIG. The second body part 320 is rotatably positioned on the end 314 of the first body part 310.

As shown in FIGS. 10 and 11, the first body portion 310 has an opening 312 through which the push button portion 342 of the bladder 340 can extend. As described below, the push button 342, the desired amount of polymerizable adhesive material applicator / dispenser 300, for example, be pressed by the user to dispense through disposable or detachable chip 350 it can. While the user's thumb or finger can be used to push the push button part 342, the applicator / dispenser 300 is gripped by the first body part 310 as a handle. For example, the user can hold the applicator / dispenser 300 as a pen and press the bush button part 342 with the index finger.

  It should be understood that the removable or separable tip 350 can have any desired structure. The tip 350 can be selected for a particular application and is not limited to the taper nozzle design shown. For example, the applicator tip can be a fibrous swab, a sponge swab, a foam swab, a brush, a spatula, and the like. Any suitable tip known or later developed can be used with the applicator / dispenser according to the present invention.

  The tip 350 can be designed to be secured at the distal end 314 of the first body portion 310 of the applicator / dispenser 300. Alternatively, the tip 350 can be secured directly to the porous plug 370 located at the open end of the bladder 340 as described below. Further, once the applicator / dispenser 300 is assembled, for example, by coupling to the distal end 314 of the first body portion 310, the tip 350 can be made non-removable.

The first body portion 310, the second body portion 320, the bladder 340 and / or the tip 350 may be any suitable material, preferably stabilizing the polymerizable adhesive material to be dispensed to avoid premature polymerization. It can be made of a material that improves the properties.

Porous plug 370 can include a polymerization initiator or rate modifier for the adhesive material to be dispensed . The porous plug 370 can be impregnated with a polymerization initiator or rate modifier, or can have a polymerization initiator or rate modifier coated on its surface.

  FIG. 11 is an exploded view of a third exemplary embodiment. As described above with respect to the first embodiment, the bladder 340 has an open end 344 with a porous plug 370 secured therein. At least the push button part 342 of the bladder 340 is made of a flexible material. Ladder 340 can be blow molded from a suitable rubber or plastic material such as, for example, polyvinyl chloride, polyethylene, polyurethane, natural rubber, nitrile rubber, and the like.

A fragile unpool 346 containing an amount of polymerizable adhesive 348 can be aligned with the bladder 340. The frangible ampere 346 can be made of any suitable material, preferably a material that improves the stability and shelf life of the polymerizable adhesive material 348. For example, the fragile unpool 346 can be made of glass. Other materials, such as plastic materials or perforated metal materials such as aluminum, can also be used for the fragile unpool 346. Similar to the embodiment of FIGS. 1-4 described above, examples of suitable unpools that can be used in the dispenser / applicator of the present invention are disclosed, for example, in US Pat. No. 5,928,611, which is hereby incorporated by reference in its entirety. Has been. Indeed, when such an unpool is used in the present invention, it is possible to use not only the unpool 346 but the entire unpool / applicator device that constitutes the porous plug 370. In such embodiments, the dispenser / applicator of the present invention is particularly suitable for dispensing or applying the adhesive contained in the topical skin adhesive product DERMABOND® available from Ethicon (Somerville, New Jersey). Is appropriate.

  The bladder 340, the push button part 342, the fragile unpool 346 and the porous plug 370 can be assembled and inserted into the space between the two pieces of the first body part 310, and the porous plug 370 is inserted into the first body part 310. The second body portion 320 extends through the open end 314 of the first body portion 310 and is rotatably positioned at the end 314 of the first body portion 310.

  As shown in FIGS. 11 and 12, the distal end 314 of the first body portion 310 includes a penetrating or cutting member 316 that extends internally. The cutting member 316 has the first and second body portions 310, 320, such that a cam surface or ramp that is located on the inner surface of the second body portion 320 presses the cutting member 316 into the fragile unpool 346. The cutting member 310 is positioned such that the fragile unpool 346 is broken by the cutting member 316 when rotated relative to each other. In relative rotation, the cam surface or ramp is in contact with the portion of the cutting member 316 that extends beyond the outer surface of the distal end 314 and presses the cutting member 316 internally against the fragile unpool 346. The cam surface or ramp provides a mechanical advantage to facilitate cutting of the fragile unpool 346.

The bladder 340 is designed to include a polymerizable adhesive 348 once the fragile unpool 346 is broken. The polymerizable adhesive 348 is affected from the bladder 340 by pressing the push button portion 342 to display the polymerizable adhesive 348 and allow it to flow through the porous plug 370. The polymerizable adhesive 348 flowing through the porous plug 370 can be applied to the desired site using the tip 350.

A controlled flow of the polymerizable adhesive 348 can be obtained by pushing the push button portion 342 to a desired degree and / or a desired number of times. In an embodiment, the volume displayed by pressing push button 342 may correspond to a desired calculated amount of polymerizable adhesive 348 to be dispensed .

As described above, the amount of polymerizable adhesive material 348 can be pre-included in the applicator / dispenser 300. The applicator / dispenser 300 can be disposable and discarded after the polymerizable adhesive material 348 in the fragile unpool 346 has been dispensed or otherwise used (ie, polymerized). Alternatively, the amount of polymerizable adhesive material 348 can be separated from the applicator / dispenser 300 and delivered to the applicator / dispenser 300 prior to use.

  In an embodiment, the user selects from various adhesive materials and / or quantities by selecting a fragile unpool and / or butter assembly (blader, unpool, and plug) to be inserted into the applicator / dispenser 300. can do. For example, a kit can be provided that includes at least one applicator / dispenser 300 and a plurality of frangible unpools 346 (or bladder assemblies). A plurality of removable or separable tips 350 can also be included in the kit.

Although the present invention is not limited to the particular design shown here, FIGS. 13-15 illustrate a fourth embodiment of the present invention (an embodiment of the present invention) . As shown in FIGS. 13 to 15, the applicator / dispenser 400 is formed by a first body part 410 and a second body part 420 that are movable relative to each other. For example, in the illustrated embodiment, the first body portion 410 can be formed by two pieces secured together to provide an open end 414 as shown in FIG. The second body part 420 is rotatably positioned on the end 414 of the first body part 410.

As shown in FIGS. 13-15, the first body portion 410 has an opening 412 through which the push button portion 442 of the bladder 440 can extend. As described below, the push button portion 442, the desired amount of polymerizable adhesive material, for example, through removable or detachable tip (not shown), to dispense from the applicator / dispenser 400, Can be pushed by the user. The user's thumb or finger can be used to push the push button portion 442 while the applicator / dispenser 400 is gripped by the first body portion 410 as a handle. For example, the user can hold applicator / dispenser 400 as a pen and press push button 442 with his index finger.

The first body portion 410, the second body portion 420, and / or the bladder 440 can be used to stabilize any suitable material, preferably the polymerizable adhesive material to be dispensed to avoid premature polymerization. It can be made of a material that improves the properties.

The porous plug 470 is positioned at the open end of the bladder 440, as further described below. The porous plug 470 can include a polymerization initiator of the polymerizable adhesive material to be dispensed , or a rate modifier. Porous plug 470 can be impregnated with a polymerization initiator or rate modifier, or have a polymerization initiator or rate modifier coated on its surface.

FIG. 15 shows an exploded view of the fourth exemplary embodiment. With respect to the first embodiment, as described above, the bladder 440 has an open end 444 with a porous plug 470 secured therein. At least the push button portion 442 of the bladder 440 is made of a flexible material. The bladder 440 can be blow molded from a suitable rubber or plastic material such as polyvinyl chloride, polyethylene, polyurethane, natural rubber, nitrile rubber, and the like.

A fragile unpool 446 containing a certain amount of polymerizable adhesive 448 is placed in bladder 440. The frangible ampere 446 can be made of any suitable material, preferably a material that improves the stability and shelf life of the polymerizable adhesive material 448. For example, the fragile unpool 446 can be made of glass. Other materials such as plastic materials or perforated metal materials such as aluminum can be used for the fragile unpool 446. Similar to the embodiment of FIGS. 1-4 described above, examples of suitable unpools that can be used in the dispenser / applicator of the present invention are disclosed, for example, in US Pat. No. 5,928,611, the entire disclosure of which is hereby incorporated by reference. Has been. In fact, when the unpool is used in the present invention, not only the unpool 446, but the entire unpool / applicator device constituting the porous plug 470 can be used. In this embodiment, the dispenser / applicator of the present invention is particularly suitable for dispensing or applying the adhesive contained in the topical skin adhesive product DERMABOND® available from Ethicon (Somerville, New Jersey). is there.

  In the fourth embodiment, the unpool 446 is surrounded by the tube 447. The tube 447 is made of any suitable material that is compatible with the particular adhesive to be applied, such as butarate or polyethylene, and can be selected based on the desired application.

  As shown, tube 447 has a hole 449 formed therein. When assembled, the tube 447 is positioned on the bladder 440 such that the hole 449 is installed with the interior of the push button 442 of the bladder 440. As described below, this allows the lowering of the push button 442 to apply pressure to release the adhesive 448. In an embodiment, the tube 447 is fixed or coupled to the bladder 440 such that the hole 449 is maintained in place.

The bladder 440, the push button part 442, the fragile unpool 446, the tube 447, and the porous plug 470 can be assembled and inserted into the space between the two pieces of the first body part 410, and the porous plug 470 Extending through the open end 414 of the one body portion 410, the second body portion 420 is rotatably positioned at the end 414 of the first body portion 410.

  As shown in FIG. 15, as described above with respect to FIGS. 11 and 12 of the third embodiment, the distal end 414 of the first body portion 410 includes an internally extending penetrating or cutting member 416. In a fourth embodiment, two cutting members 416 are provided that can be located opposite each other. The cutting member 416 forces the first and second body portions 410, 420 so that cam surfaces or ramps located on the inner surface of the second body portion 420 press the cutting member 416 into the fragile ampere 446. The cutting member 416 is positioned such that the fragile unpool 446 is broken by the cutting member 416 when rotated relative to each other. In relative rotation, the cam surface or ramps extend beyond the outer surface of the distal end 414 and press the cutting member 446 internally against the tube 447 for applying pressure on the fragile unpool 446. The corresponding cutting member 416 and the cam surface or ramp are in contact. The cam surface or ramp provides mechanical advantages for facilitating breakage of the fragile unpool 446. Further, since the cutting members 416 are located opposite each other, the fragile unpool 446 is held in a location that facilitates destruction.

  As shown in FIG. 14, the applicator / dispenser 400 has a visual indicator 450 that allows the user to determine whether the applicator / dispenser 400 is activated. The visible indicator 450 is a set of indicated features or markings that allow the user to identify when the first and second body portions 410, 420 rotate relative to each other. It can be set. For example, the visual indicator 450 can be positioned from the beginning prior to activation of the applicator / dispenser 400, as shown in FIG. The relative rotation of the first and second body parts 410, 420 is therefore clearly indicated by the visual indicator 450 without being positioned anymore.

  Alternatively or additionally, the visible indicator 450 may be a second indicator that indicates when the first and second body portions 410, 420 rotate relative to a position where the unpool 446 is broken by the cutting member 416. It can consist of a feature / marking or feature / marking pair.

In a fourth embodiment, the tube 447 is designed to contain a polymerizable adhesive once the fragile ampere 446 is broken. The polymerizable adhesive 448 pushes the push button portion 442 of the bladder 440 and pressure is applied through the hole 449 to move the polymerizable adhesive 448, which flows through the porous plug 470, thereby causing the tube 447. Can be affected. The polymerizable adhesive 448 that flows through the porous plug 470 is then applied to the desired site.

A controlled flow of the polymerizable adhesive 448 can be obtained by pressing the push button portion 442 for a desired degree and / or a desired number of times. In an embodiment, the volume moved by pushing the push button 442 may correspond to a desired calculated amount of adhesive 448 to be dispensed .

As described above, the amount of polymerizable adhesive material 448 can be pre-included in the applicator / dispenser 400. The applicator / dispenser 400 can be disposable or disposed after dispensing or otherwise using (ie, polymerizing) the amount of polymerizable adhesive material 448 in the fragile unpool 446. Alternatively, the amount of polymerizable adhesive material 448 can be separated from the applicator / dispenser 400 and supplied to the applicator / dispenser 400 prior to use.

  In an embodiment, the user can select various adhesive materials and / or by selecting fragile unpools, tubes, and / or bladder assemblies (bladers, unpools, tubes and plugs) that are inserted into the applicator / dispenser 400. The amount can be selected. For example, a kit can be provided that includes at least one applicator / dispenser 400 and a plurality of frangible unpools 446 (or bladder assemblies).

  By making parts of the applicator / dispenser of the present invention consisting of materials that tend to stabilize the adhesive monomer composition, the adhesive composition is known as an additive to the adhesive monomer composition and in the art. It is possible and preferred in embodiments of the present invention to be free or substantially free of one or more stabilizer components, such as those used. This can even reduce or eliminate the need for polymerization initiators or accelerators. For example, suitable materials include those disclosed in pending US patent application Ser. No. 09 / 874,039 filed Jun. 6, 2001, hereby incorporated by reference in its entirety. For example, suitable materials include halogenated and / or fluorinated materials.

Suitable applicator tips, either separable tips or porous plugs as described above for the applicator / dispenser of the present invention include swabs, brushes, spatulas, syringes, syringes and the like. Any suitable applicator tip that allows application of the adhesive composition to the desired site can be used, and therefore different applicator tips can be suitable for different application methods. The applicator tip can have a variety of suitable shapes including, but not limited to, conical, cylindrical, chiseled, or polygonal shapes such as rectangular and trapezoidal. The length and size of the chip can be varied depending on various application parameters. The tip is removable from the applicator body and can be an integral part of the applicator.

The replaceable chip can be made of any of a variety of materials including polymerizable materials such as, for example, plastics, foams, rubbers, thermoplastics, films or membranes. In addition, the replaceable chip can be made of materials such as glass, paper, ceramics, cardboard and the like. The replaceable chip material can be porous, absorbent, or adsorptive in order to improve and facilitate application of the adhesive composition. In general, the only limitation on the materials used to assemble the chip is that the chip must be well compatible with the composition to be dispensed , and undesirable effects on the composition can be caused between the chip and the composition. It is not prevailing during bonding. Thus, according to an embodiment of the invention when containing an adhesive composition, for example when already absorbed into a chip, or adsorbed into a chip, or in direct contact with a chip, the chip is Preferably, it does not consist of a material that tends to stabilize or at least accelerates the polymerization of the adhesive monomer composition. If the chip is made of a polymerizable material, the polymerizable material can be the same as or different from those specified above. Suitable designs for chips that can be used in accordance with the present invention are described, for example, in US patent application Ser. No. 08 / 488,411, filed Jun. 7, 1995, which is hereby incorporated by reference in its entirety. No. 09 / 069,979 filed on Apr. 30, 1997, No. 09 / 069,875 filed Apr. 30, 1998, No. 09/385, filed Aug. 30, 1999 No. 030.

Further, the dispenser / applicator tip of the present invention can be provided in any of various sizes depending on the desired use of the product. For example, a standard preferred swab size can be a rectangular shape having a size of about 1.3 cm × 1.0 cm × 0.64 cm. However, the shape of the chip and to apply for a given application. Or, if the size determines the amount of adhesive material, a larger or smaller size can be used. Thus, for example, dispensers / applicators can use larger (and / or more absorbent) tips when intended for applications requiring large amounts of adhesive material, while small amounts of adhesive material Smaller (and / or less absorbent) chips can be used if intended only for applications that require only. Tailoring the chip size, or absorbency / adsorbability, to the amount of adhesive required can help prevent depletion of the adhesive material. For example, when large chips (and large amounts of adhesive) are used for small adhesive applications, the adhesive remaining on the chip is generally wasted due to premature polymerization of the adhesive on the chip.

  In addition to polymerization initiators or rate modifiers, the chip can include drugs, anesthetics, and / or other materials to be applied.

  The applicator / dispenser of the present invention can be applied to various materials for the purpose of protecting, sealing, and bonding the surface together with the polymerizable adhesive composition. Suitable materials include, but are not limited to, metal, plastic, rubber, wood, ceramics, fiber, cement, paper, living tissue and the like. For example, systems capable of polymerizing and / or cross-linking tissue bonding, preventing bleeding or covering open wounds, systems for the transfer of therapeutic or other biologically active agents, and other biomedicine Can serve as a general purpose. They can, for example, seal tissue that has been surgically sharply cut or torn by trauma, set a damaged skeleton, inhibit blood flowing from the wound, help restore and regenerate live tissue Treating burns, shaping skin or other surgical or surface trauma (abrasion, replaced or live skin, and / or stomatitis), protecting vulnerable tissues (e.g., artificial ), And find use in providing structural implants.

  In an embodiment, the adhesive material is preferably a monomeric (including prepolymer) adhesive composition. In an embodiment, the monomer is a 1,1-2 substituted ethylene monomer, such as alpha cyanoacrylate. Preferred monomer compositions of the present invention, and polymers formed therefrom, are tissue adhesives, sealants to prevent bleeding or cover open wounds, and other absorbable and non-absorbable biomedicines. Useful in industrial applications. They can, for example, shape tissue that has been surgically sharply cut or torn by trauma, transporting drugs, treating burns, shaping skin or other surgical or surface trauma (abrasion, replacement Find use in helping to recover hernia, interarticular cartilage recovery, living tissue recovery and regeneration). Other preferred monomer compositions and polymers formed therefrom are useful in industrial and household applications, for example, in bonding rubber, plastic, wood, composites, fibers, and other natural and synthetic materials. It is.

  Monomeric (including prepolymer) adhesive compositions can include one or more polymerizable monomers. Preferred monomers that can be used in the present invention are readily polymerizable, eg, anionically polymerizable, free radically polymerizable, or polymerizable by zwitterions or ion pairs to form a polymer. Such monomers, including those that form polymers, are not required, but are biodegradable. Such monomers include, for example, Leung et al., U.S. Pat.Nos. 5,328,687 and 5928611, U.S. Patent Application No. 09 / 430,177 filed October 29, 1999, U.S. Pat. No. 6,183,593. Preferred monomers include, but are not limited to, 1,1-2 substituted ethylene monomers such as α-cyanoacrylate, about 1 to about 20 or more carbon atoms, preferably about 2 to about 12, more preferably about Alkyl α-cyanoacrylates having an alkyl chain length of 3 to about 8 carbon atoms. Other suitable monomers include, but are not limited to, alkyl ester cyanoacrylate monomers, such as U.S. patent application Ser. No. 09 / 630,437, filed Aug. 2, 2000, which is hereby incorporated by reference in its entirety, and 2001. This is disclosed in US patent application Ser. No. 09 / 919,877 filed Aug. 2.

  The α-cyanoacrylates of the present invention can be prepared by several methods known in the art. US Pat. Nos. 2,721,858, 3,325,411, 3,995,641, and 4,364,764, each of which is hereby incorporated by reference in its entirety, disclose methods of preparing α-cyanoacrylates.

  If desired, applications according to the present invention may include a wide variety of any additional materials, either mixed into the polymerizable composition or in a separate compartment from the gunshot composition. Can do. Examples of suitable additional materials include, but are not limited to, plasticizers, thixotropic agents, thickeners, natural or synthetic rubbers, stabilizers, pH modifiers, bioactive agents, crosslinkers, chain transfer agents, fiber reinforcing agents. , Colorants, preservatives, formaldehyde reducing or cleaning agents, fragrances, perfumes, mixtures thereof, and the like.

  The adhesive material can also optionally include at least one other plasticizer that helps impart flexibility to the polymer formed from the monomers. The plasticizer preferably contains little or no moisture and should not significantly affect monomer stability or polymerization. Examples of suitable plasticizers include, but are not limited to, tributyl citrate, acetyl n-butyl citrate (ATBC), polymethyl methacrylate, polydimethylsiloxane, hexadimethylsilazane, isopropyl myristate, isopropyl palmitate, and Including others listed in US patent application Ser. No. 09/471392 filed on Dec. 23, 1999, which is incorporated by reference in its entirety.

  The adhesive material can also optionally include at least one thixotropic agent. Suitable thixotropic agents are known to those skilled in the art and include, but are not limited to, silica gels such as those treated with silyl isocyanate, and selectively surface treated titanium dioxide. Examples of suitable thixotropic and thickening agents are disclosed in U.S. Pat. No. 4,720,513, which is hereby incorporated by reference in its entirety, and U.S. Patent Application No. 09/374207, filed August 12, 1999. .

  The adhesive material can also optionally include a thickener. Suitable thickeners include poly (2-ethylhexyl methacrylate), poly (2-ethylhexyl acrylate), and US patent application Ser. No. 09 filed on Dec. 23, 1999, which is hereby incorporated by reference in its entirety. No. 471392, and others listed in US patent application Ser. No. 09/374207, filed Aug. 12, 1999.

  The adhesive material can optionally include at least one natural or synthetic rubber to impart resistance. Suitable rubbers are known to those skilled in the art. Such rubbers include, but are not limited to, dienes, styrene, acrylonitrile, and mixtures thereof. Examples of suitable rubbers are disclosed in US Pat. Nos. 4,313,865, and 4,560,723, which are hereby incorporated by reference in their entirety.

  The adhesive material can also optionally include one or more stabilizers, preferably both at least one anionic gas phase stabilizer and at least one anionic liquid phase stabilizer. The composition can also optionally include at least one free radical stabilizer in addition to or instead of the anionic stabilizer. These stabilizers can prevent premature polymerization. Suitable anion and free radical stabilizers are filed on US patent application Ser. No. 09/471392 filed Dec. 23, 1999 and Jun. 18, 1998, the disclosures of which are hereby incorporated by reference in their entirety. May include those listed in 09 / 099,457.

  However, as noted above, a particular advantage of the present invention, such as the embodiment where a stabilizing material is used, is that separate stabilizers can be omitted from the composition. Therefore, in embodiments, it is preferred that the polymerizable composition be free of at least substantially no additional stabilizer.

  The adhesive material has a degradation rate of the resulting polymer as disclosed in US patent application Ser. No. 08 / 714,288 filed Sep. 18, 1996, which is hereby incorporated by reference in its entirety. A pH adjuster can also be included to control.

  The adhesive material of the present invention comprises at least one biologically compatible agent (also referred to herein as “formaldehyde concentration reduction” effective to reduce the active formaldehyde concentration produced during biodegradation of the polymer in vivo. Also referred to as “agent”). Preferably, this component is a formaldehyde removal compound. Examples of formaldehyde removal compounds useful in the present invention include sulfites, bisulfites, mixtures of sulfites and bisulfites, and the like. Additional examples of formaldehyde scavenging compounds useful in the present invention and methods for their implementation are described in Leung et al. US Pat. And 5624669.

  In order to improve the bond strength of the adhesive formed from the adhesive material of the present invention, a bifunctional monomer crosslinking agent can be added to the monomer composition of the present invention. Such crosslinking agents are known. U.S. Pat. No. 3,940,362 to Overfults et al., Which is hereby incorporated by reference in its entirety, discloses an exemplary cross-linking agent.

  The adhesive material of the present invention can further contain a fiber reinforcing agent and a colorant such as a dye, a pigment, and a pigment dye. Examples of suitable fiber reinforcements include PGA microfibrils, collagen microfibrils, and others described in US patent application Ser. No. 09/471392 filed Dec. 23, 1999, which is hereby incorporated by reference in its entirety. including.

  The polymerizable adhesive material useful in the present invention can further comprise one or more preservatives to extend the shelf life of the composition. Suitable preservatives and methods for selecting them and incorporating them into the composition are disclosed in US patent application Ser. No. 09/430180, which is hereby incorporated by reference in its entirety.

  In an embodiment of the present invention, the adhesive material and / or the applicator / dispenser part is a polymerization initiator, accelerator, rate modifier, and / or crosslink for initiating polymerization and / or crosslinking of the polymerized monomer material. Additional materials such as agents can be included. Such initiators, accelerators, rate modifiers, and / or crosslinkers can be suitably included in the applicator tip, adhesive material, and / or the like.

  In embodiments of the present invention, especially if the adhesive material does not adhere to the applicator tip prior to use, additional components such as polymerization initiators and / or accelerators, anesthetics, drugs, etc., or polymerization into the applicator tip It is possible to incorporate even any of the various additives described above for possible adhesives. This is advantageous, for example, when a pass-through initiator or accelerator is needed to provide the desired cure rate of the adhesive once applied, or when additional processing is required. In addition, this is done when an additional stabilizer, or polymerization initiator, must be added to the adhesive composition in the assembly to overcome the cure rate loss that often occurs when the stabilizer is added. It is advantageous in embodiments.

  In an embodiment, the initiator or accelerator material is an initiator and / or rate modifier for the polymerization and / or crosslinking of polymerizable monomers. As used herein, a polymerization initiator is a substantially dry tissue (i.e. substantially free of plasma, tissue fluid, etc.) applied to the monomer composition at ambient temperature, e.g., approximately 21-25 ° C. Any material that will polymerize in less than 300 seconds. Preferably, the initiator polymerizes the monomer composition at ambient temperature in less than 150 seconds, more preferably 60, 90 or 130 seconds. As used herein, a polymerization rate modifier is any material that alters the rate at which a polymerizable monomer polymerizes in the absence of that material. Preferably, the rate modifier accelerates the polymerization reaction rate, although it may reduce its rate, especially with respect to the first working monomer.

  The material can be applied to the applicator tip by, for example, spraying, dipping, injecting, brushing the applicator tip with a liquid medium containing a polymerization initiator or accelerator. The tip is preferably applied by dipping or injecting. For example, the tip can be applied onto the tip through a liquid medium pump, such as a syringe. A method of applying a polymerization initiator or accelerator to an applicator tip is described by Leung et al., US Pat. No. 5,928,611, filed Apr. 30, 1998, which is hereby incorporated by reference in its entirety. No. 08/920876, filed Aug. 29, 1997, and 09/430177, filed Oct. 29, 1999.

Specific initiators and accelerators for specific monomers can be readily selected by those skilled in the art without undue experimentation. Control of the molecular weight distribution of the applied adhesive can be improved by selection of initiator or accelerator concentration and functionality relative to the selected monomer. Suitable polymerization initiators and accelerators for the cyanoacrylate composition include, but are not limited to, detergents, surfactants such as polysorbate 20 (eg Tween 20® ICI Americas), polysorbate 80 (eg Tween 80 ( Surfactants including non-ionic surfactants such as ICI Americas® and poloxamers, cationic surfactants such as tetrabutylammonium bromide, benzalkonium chloride or pure components thereof and benzethonium chloride, octylic acid Anionic surfactants such as stannous (tin (II) 2-ethylhexanoate) and sodium tetradecyl sulfate, and amphoteric or zwitterions such as dodecyldimethyl (3-sulfopropyl) ammonium hydroxide and internal salts Surfactants; imidazole, tryptoamine, Amines, imines and amides such as elemental, arginine and povidin; phosphine, phosphite and phosphonium salts such as triphenylphosphine and triethyl phosphite; alcohols such as ethylene glycol, methyl gallate, sodium bisulfate, Inorganic bases and salts such as magnesium hydroxide, calcium sulfate and sodium silicate; sulfur compounds such as thiourea and polysulfides; macrocyclic esters such as monensin, nonactin, crown esters, calixarene and polymeric epoxides; Cyclic and acyclic carbonates such as diethyl; phase change catalysts such as Aliquat® 336 (General Mills, Inc., Minneapolis, Minn.); Organometallics, manganese acetylacetonate; Agents, and radicals such as di-T- butyl peroxide, and azobisisobutyronitrile, a biologically active compound or agent.

  In a preferred embodiment, the initiator has a biologically active substance, alkylbenzyldimethylammonium chloride (benzalkonium chloride, BAC), a pure component thereof, or a mixture thereof, in particular having 6 to 18 carbon atoms. Tetravalent ammonium halogen such as benzethonium chloride, sulfadiazine salts. Cobalt naphthenate can be used as a peroxide promoter. Other suitable biologically active substances are disclosed in Leung et al., US Pat. No. 5928611, filed Aug. 29, 1997, US patent application Ser. No. 09/430176 filed on Oct. 29 and 09 / 430,177 filed Oct. 29, 1999.

  The adhesive material in the present invention can also consist of a drug. Encapsulation of the drug is often desirable in compositions intended for pharmaceutical use. The drug can be added to the monomer containing the adhesive composition prior to packaging, or to either the applicator tip or other part. Therefore, the agent can be applied to the tissue before or simultaneously with the application of the monomer-containing adhesive composition. In addition to reinforcing its medicinal effect, the polymerizable monomer composition together to initiate polymerization of the monomer or to adjust (eg, accelerate) the polymerization rate of the monomer to form a polymeric adhesive Drugs can be selected to function in conjunction with. The appropriate combination of drug and polymerizable monomer can be readily determined by one skilled in the art. When applied topically (ie, directly to tissue), the drug can be delivered in a pharmaceutically effective amount.

  Examples of such drugs include, but are not limited to, antibiotics, antibacterials, antiseptics, bacteriocins, bacteriostats, disinfectants, steroids, anesthetics, bactericides, anti-inflammatory agents, antibacterial agents, antiviral agents, antitumors Agents, growth promoters, and mixtures thereof.

  Exemplary drugs include, but are not limited to, quaternary ammonium halides such as benzalkonium chloride, benzethonium chloride, chlorhexidine sulfate, gentamicin sulfate, hydrogen peroxide, and quinolone thioureas, Silver salts including silver acetate, silver benzoate, silver carbonate, silver chloride, silver citrate, silver iodide, silver nitrate, and silver sulfate, and sodium hypozinc acid, but are not limited to silver, sodium, and zinc Including sulfadiazine salts such as salts and mixtures thereof.

  Preferred agents are those that are anions, assist in radical generation, ion pairs, or themselves radicals.

  In an embodiment, the medicament is preferably a fourth such as an alkyl benzyldimethylammonium chloride (benzalkonium chloride; BAC) having an alkyl group containing 6 to 18 carbon atoms, a pure component thereof, or a mixture thereof. A quaternary ammonium halogen compound, benzethonium chloride, or a sulfadiazine salt such as a silver, sodium, or zinc salt.

  The drug can have a pharmacological effect only at the site of application (ie, limited to the tissue to which it is applied) or it can have a systemic effect (systemically, it means that the drug is in the patient's body It means not only having an effect through, but also at a specific site other than the site of application). In embodiments where the drug is applied in an amount sufficient to exhibit systemic drug activity, it is absorbed and transported, or the site or sites within the patient where drug activity is desired, For example, it can contribute through blood vessels and lymphatic system. The medicament can be in the form of a solid, for example a powder or solid film, or in the form of a liquid, for example water, a viscous or pasty substance. The drug can also be synthesized with various additives such as surfactants, emulsifiers, carriers and the like.

  The polymerizable and / or cross-linking material can be straight (without additional compounds) or in a solvent, emulsion, or suspension. Suitable solvents according to the present invention include alcohols, ether alcohols, hydrocarbons, halogenated hydrocarbons, ethers, acetals, ketones, esters, acids, sulfur or nitrogen containing organic compounds, mixtures thereof, and the like. Other suitable solvents are disclosed in Hughes et al. US Pat. No. 5,130,369, Hattori et al. 5216096, which is hereby incorporated by reference in its entirety. These solvents can be used alone or in combination of two or more. They can also be used in combination with water to the extent that the polymerizable and / or cross-linking material dissolves or suspends in the mixture. The total amount of solvent that can be incorporated into the polymerizable and / or cross-linked material can be 0-99, preferably 1-50, more preferably 3-25% by weight. Of course, the amount selection depends on the desired monomer and process conditions, and amounts outside these ranges are acceptable.

In an embodiment, the monomer composition and / or its packaging is preferably disinfected. Disinfection of the monomer composition and / or its packaging can be performed by techniques known to those skilled in the art and is preferably performed by methods including, but not limited to, chemical, physical, and / or irradiation methods. Examples of chemical methods include, but are not limited to, exposure to ethylene oxide or hydrogen peroxide gas phase. Examples of physical methods include, but are not limited to, heating (dry or moisture) or disinfection with a retort can. Examples of radioactive methods include, but are not limited to, gamma radiation, electron beam irradiation, and microwave irradiation. A preferred method is electron beam irradiation as disclosed in US patent application Ser. No. 09/025472, filed Feb. 18, 1998, which is hereby incorporated by reference in its entirety. The composition must exhibit a low level of toxicity to living tissue during its beneficial lifetime. In a preferred embodiment of the invention, the composition is sterilized to provide a sterilization assurance level (SAL) of at least 10 ⁻³ . In embodiments, the sterilization assurance level can be at least 10 ⁻⁴ , or at least 10 ⁻⁵ , or at least 10 ⁻⁶ . Further details of sterilization are disclosed in the incorporated US patent application Ser. No. 09/874039.

  It should be understood that the individual features of the various exemplary embodiments can be included or excluded as desired for a given application. Thus, all possible combinations of the described features are considered to be included in the present invention.

  Thus, while the invention is described in terms of exemplary embodiments, it should be understood that the invention is not limited to the specific configuration of those embodiments. Those skilled in the art will recognize that various modifications and / or changes can be made to these embodiments within the scope of the present invention.

FIG. 1 shows a perspective view of a first exemplary embodiment of the present invention. FIG. 2 shows a perspective view of the exemplary embodiment of FIG. 1 illustrating the operation of the applicator / dispenser. FIG. 3 shows a perspective view of the bladder and unpool of the exemplary embodiment of FIG. FIG. 4 shows a partial cross-sectional view of the exemplary embodiment of FIG. FIG. 5 shows a perspective view of a second exemplary embodiment of the present invention. 6 shows a perspective view of the exemplary embodiment of FIG. 5 illustrating the operation of the applicator / dispenser. FIG. 7 shows a cross-sectional view of the exemplary embodiment of FIG. FIG. 8 is a perspective view of the slider body of the exemplary embodiment of FIG. FIG. 9 is a partial cross-sectional view of the exemplary embodiment of FIG. FIG. 10 is a perspective view of a third exemplary embodiment of the present invention. FIG. 11 is an exploded view of the exemplary embodiment of FIG. FIG. 12 is a partially enlarged view of the exemplary embodiment of FIG. FIG. 13 is a top perspective view of a fourth exemplary embodiment of the present invention. 14 is a bottom perspective view of the exemplary embodiment of FIG. FIG. 15 is an exploded view of the exemplary embodiment of FIG.

Claims (22)

An applicator / dispenser assembly for dispensing and / or applying a polymerizable monomer adhesive material comprising:
A first body part and a second body part, at least one of which is rotatable relative to the other of the first and second body parts;
A cavity in at least one of the first body portion and the second body portion;
A penetrating or cutting member installed in the first body part, and an assembly comprising:
The rotation of one of the first and second body portions relative to the other of the first and second body portions destroys an adhesive container at least partially disposed within the cavity; Moving the penetrating or cutting member into the cavity, and the penetrating or cutting member comprises at least two opposing members extending inwardly and disposed opposite each other , the first and second The at least two opposing members move into the cavity when one of the first and second body portions is rotated relative to the other of the body portion; A featured assembly.   And a second container having at least one opening and surrounding a container of adhesive material, wherein one rotation of the first and second body parts relative to the other of the first and second body parts comprises: The assembly of claim 1 wherein the container containing the adhesive material is broken without moving the penetrating or cutting member to cut the second container.   The assembly of claim 2, wherein the second container includes an open hole.   The assembly of claim 1, wherein the adhesive material comprises a polymerizable monomer adhesive material.   The assembly of claim 1 wherein the adhesive material comprises a polymerizable 1,1-2 group substituted ethylene monomer blend.   The assembly of claim 1, wherein the adhesive material comprises a cyanoacrylate formulation.   The assembly according to claim 1, wherein the second body portion is rotatable relative to the first body portion. And a cam surface disposed on one of the first and second body portions other than one of the first and second body portions on which the penetrating or cutting member is disposed,
8. Assembly according to claim 7, wherein the rotation of the second body relative to the first body moves the penetrating or cutting member into the cavity by contacting the cam surface and the penetrating or cutting member. Goods.   9. The assembly of claim 8, wherein the cam surface comprises at least two surfaces corresponding to at least two opposing members of the penetrating or cutting member. A bladder that is at least partially disposed within the cavity and at least partially flexible;
One of the first and second body portions relative to the other of the first and second body portions, and a container of adhesive material disposed within the bladder and at least partially located within the cavity. The assembly of claim 1 wherein one rotation moves the penetrating or cutting member and destroys the container.   And a plug member at least partially disposed in the opening of the bladder, wherein the plug member is made of a material having at least one of a porous property, an absorptive property, and an absorptive property. The assembly according to claim 10.   12. An assembly according to claim 11, wherein the plug member comprises an applicator tip.   The assembly of claim 11, wherein at least one of a drug, a polymerization initiator, a polymerization rate modifier, and a stabilizer for the polymerizable monomer is in or on the plug member. A kit comprising at least one applicator / dispenser assembly for dispensing and / or applying a polymerizable monomer adhesive material,
The applicator / dispenser assembly includes at least one rotatable first and second body portions relative to the other of the first and second body portions, and the first and second body portions. A cavity in at least one of the body parts, and a penetrating or cutting member installed in the first body part,
One rotation of the first and second body portions relative to the other of the first and second body portions moves the penetrating or cutting member into the cavity;
The kit includes a plurality of containers of adhesive material disposed at least in part for placement in a cavity of the at least one applicator / dispenser assembly; Rotation of the first and second body portions relative to each other moves the penetrating or cutting member and destroys one of the containers at least partially installed in the cavity ;
The penetrating or cutting member includes at least two opposing members that extend inwardly and are disposed at opposing positions, and are relative to the other of the first and second body portions. A kit wherein the at least two opposing members move into the cavity when one of the first and second body portions rotates . A method for applying / dispensing adhesive material, comprising: obtaining an applicator / dispenser assembly according to claim 1;
Rotating one of the first and second body parts relative to the other of the first and second body parts, moving the penetrating or cutting member, destroying the container;
Dispensing the adhesive material from the cavity.   16. The method of claim 15, further comprising applying the dispensed adhesive material to the material to be bonded.   The method of claim 16, wherein the substance to be bound is tissue.   Operating one of the first and second fuselage parts relative to the other of the first and second fuselage parts is relative to the other of the first and second fuselage parts. 16. The method of claim 15, comprising rotating one of the first and second body portions. An applicator / dispenser assembly for dispensing and / or applying a polymerizable monomer adhesive material comprising:
A first body part and a second body part, wherein at least one of the first and second body parts is rotatable relative to the other of the first and second body parts; The torso,
A space at least partially in and between the first and second body parts;
A penetrating or cutting member installed in the first body part,
The relative rotation of one of the first and second body portions with respect to the other of the first and second body portions is at least partially into a space in and between the first and second body portions. Moving the penetrating or cutting member;
The applicator / dispenser further comprises a container of adhesive material at least partially disposed in a space in and between the first and second body portions, the first and second body A relative rotation of one of the parts relative to the other of the first and second body parts moves the penetrating or cutting member to destroy the container ;
The penetrating or cutting member includes at least two opposing members that extend inwardly and are disposed at opposing positions, and are relative to the other of the first and second body portions. An assembly according to claim 1, wherein the at least two opposing members move into the space when one of the first and second body portions is rotated . An applicator / dispenser assembly for dispensing and / or applying a polymerizable monomer adhesive material comprising:
A first body part and a second body part, wherein at least one of the first and second body parts is rotatable relative to the other of the first and second body parts; The torso,
A cavity in at least one of the first and second body parts;
A penetrating or cutting member installed in the first body part,
Relative rotation of one of the first and second body portions relative to the other of the first and second body portions moves the penetrating or cutting member into the cavity, at least partially within the cavity. Breaking the disposed adhesive container, and at least a portion of the at least one of the first and second body portions defining the cavity is formed from a material that stabilizes the polymerizable monomer adhesive material ;
The penetrating or cutting member includes at least two opposing members that extend inwardly and are disposed at opposing positions, and are relative to the other of the first and second body portions. The assembly of claim 1, wherein the at least two opposing members move into the cavity when one of the first and second body portions is rotated . An applicator / dispenser assembly for dispensing and / or applying a polymerizable monomer adhesive material comprising:
A first body part and a second body part, wherein at least one of the first and second body parts is movable relative to the other of the first and second body parts. The torso,
A cavity in at least one of the first and second body parts;
A penetrating or cutting member installed in the first body part,
Relative movement of one of the first and second body portions relative to the other of the first and second body portions moves the penetrating or cutting member into the cavity, and the second body portion is Rotatable relative to the first body portion, the applicator / dispenser further comprising a cam surface disposed on the second body portion;
Relative rotation of the second body portion relative to the first body portion moves the penetrating or cutting member into the cavity by bringing the cam surface into contact with the penetrating or cutting member, and into the cavity. Destroy the adhesive container, at least part of which is placed ,
The penetrating or cutting member includes at least two opposing members that extend inwardly and are disposed at opposing positions, and are relative to the other of the first and second body portions. The assembly of claim 1, wherein the at least two opposing members move into the cavity when one of the first and second body portions is rotated . An applicator / dispenser assembly for dispensing and / or applying a polymerizable monomer adhesive material comprising:
A first body part and a second body part, wherein at least one of the first and second body parts is rotatable relative to the other of the first and second body parts; The torso,
A cavity in at least one of the first and second body parts;
A penetrating or cutting member installed in the first body part,
Rotation of one of the first and second body portions relative to the other of the first and second body portions moves the penetrating or cutting member into the cavity;
The applicator / dispenser further comprises:
A bladder that is at least partially disposed within the cavity and at least partially flexible;
A container of adhesive material disposed within the bladder and at least partially positioned within the cavity, wherein one of the first and second body portions is relative to the other of the first and second body portions. Rotation rotates the penetrating or cutting member, destroying the container ,
The penetrating or cutting member includes at least two opposing members that extend inwardly and are disposed at opposing positions, and are relative to the other of the first and second body portions. The assembly of claim 1, wherein the at least two opposing members move into the cavity when one of the first and second body portions is rotated .

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